Unsure on efficacy, NICE passes J&J’s Darzalex to CDF

The bone marrow cancer therapy is now temporarily approved as a fourth-line treatment

Johnson & Johnson’s multiple myeloma drug Darzalex has failed to win over NICE for a second time, but will be made available via the Cancer Drugs Fund (CDF) as an interim measure.

The UK’s health technology assessment agency rejected Darzalex (daratumumab) as a third-line treatment for patients with multiple myeloma last March, to the consternation of the company and patients who have failed other drugs for the blood cancer, promoting J&J to ask for a review of fourth-line use.

Darzalex is approved in the EU to treat adults with relapsed and refractory multiple myeloma who have been treated before with proteasome inhibitor and an immunomodulatory agent and whose disease as progressed on their last therapy.

Now, a second NICE appraisal has resulted in the agency saying it does not have enough information to make a definitive judgment on the efficacy of the drug for routine NHS use, but that it can be made available via the CDF as a fourth-line treatment for the disease.

NHS England and Janssen have agreed a commercial access agreement for the treatment, which replaces the previous patient access scheme. The financial terms of the agreement are confidential.

Janssen is pleased by the outcome, and Jennifer Lee - its director of health economics - said: “We are delighted to be able to provide an extra line of therapy to patients and doctors across the UK.” The Scottish Medicines Consortium backed NHS funding for fourth-line use of the drug last year.

News that the drug would be available at least via the CDF was also welcomed by Myeloma UK, and its chief executive - Rosemarie Finlay - said this was “heartening news for myeloma patients and their families”.

“Daratumumab is an exciting and innovative new treatment which has been shown to have a very beneficial effect on length of remission in patients who respond,” she added. “This is an important new treatment option for patients whose myeloma has come back and who may have exhausted other treatment options, or who are not responding well to other types of myeloma treatments”.

Last year, NICE said it was unable to make a recommendation about use of Darzalex in combination with Celgene’s Revlimid (lenalidomide) and dexamethasone for relapsed and refractory myeloma because Janssen had not submitted evidence in support of that indication.

It is also considering the combination of Janssen’s drug and Takeda’s Velcade (bortezomib) in relapsed or refractory myeloma, and is due to publish its first findings later this year.